In the dynamic landscape of healthcare regulations, ensuring compliance with the Ministry of Health and Prevention (MoHAP), UAE, is paramount for product owners. Uncertainty regarding how products are classified within the UAE market can pose challenges for manufacturers and distributors alike. However, MoHAP offers a streamlined pathway through its Product Classification process, shedding light on the regulatory status of various products.
Understanding MOHAP Product Classification Process in UAE
For product owners seeking clarity on their product's regulatory standing in the UAE, the Product Classification request with MoHAP serves as a beacon. This regulatory pathway facilitates the classification of products based on various parameters such as Presentation, Composition, Use, and Design. It's important to note that requirements may vary based on the nature of the product, its risk class, and regulatory status.
Key Components of MoHAP Product Classification Process in UAE
The Product Classification letter issued by MoHAP encompasses vital information essential for navigating the regulatory landscape. It includes details such as:
Product classification based on MoHAP guidelines
Applicable laws governing the product within the UAE
Determination of whether the product requires registration by MoHAP
Distinction Between MoHAP’s Product Classification and Registration Pathways
It's crucial to understand that product classification is not equivalent to registration. Instead, it serves as a guide on regulatory and registration requirements. The classification provided by MoHAP is based on the information submitted by the product owner in the official classification application. Any changes to the product or its intended use may necessitate a fresh application for classification to ensure compliance. While product classification is open to all types of companies and individuals seeking clarity on their product's regulatory standing, registration is a privilege reserved for medical warehouses possessing licenses issued by MoHAP.
Documentation Requirements for MoHAP Product Classification in UAE
To initiate the Product Classification process, certain documents must be submitted, including:
Additional Requirements for Medical Devices Product Classification in UAE
Medical devices entail specific considerations, including detailed accessory lists, variations in sizes, and compliance with relevant laws governing patient data processing. Additional requirements for Medical Devices encompass various considerations to ensure thorough classification and adherence to regulatory standards:
Accessory Identification: For devices with numerous accessories, a comprehensive table listing accessory names and codes, if applicable, must be provided. Each page of this list should be stamped by both the manufacturer/supplier abroad and the local agent.
Size Variation: Products with multiple sizes can be submitted under one application. However, variations in models, configurations, uses, or dosage forms are treated as distinct applications.
Treatment of Devices and Accessories: Each device and its accessories are treated as a single product for classification purposes, with corresponding fees applied accordingly.
Differentiating Supporting Items: Supporting items targeting different areas of the body or functions of the device are considered separate products, subject to applicable fees.
First Aid Kits Classification: Individual items within first aid bags and kits are classified separately, with associated fees applied accordingly.
Classification of Dentistry Kits: Dentistry kits are classified based on their components. Tools and equipment within the same group are classified together, while products containing pharmaceutical and chemical substances are treated as separate applications.
Laboratory Reagents Handling: Reagents linked to specific systems/analyzers are treated as a single application, while separate individual reagents or rapid test kits require separate applications.
Products granted clearance as medical devices restricted to professional use require additional clearance from the UAE MoHAP Importation section/Drug Department. These products are restricted to supply only to licensed healthcare facilities and professionals within the UAE. Products cleared as over-the-counter medical devices may be placed in pharmacies for OTC use, subject to relevant regulations. Medical devices containing software for processing patient data must comply with UAE Federal Law No.2 of 2019 and MOHAP Ministerial Decree 51/2021 regarding patient data handling, processing, and transfer.
MoHAP Product Classification Application Submission Process in UAE
The application submission process involves logging into the MoHAP website or smart app using UAEPASS, filling out product details, attaching required documents, and making payment. Payment is facilitated via electronic payment channels, including MOHAP’s Payment Gateway utilizing e-dirham. Upon successful payment, the application can be promptly submitted.
MoHAP Product Classification Application Review Process in UAE
Understanding the Ministry of Health and Prevention (MoHAP) review process is essential for applicants seeking product classification in the UAE. The MoHAP review process may entail corrections, sample requests, appointment scheduling, and analysis requests, as deemed necessary by reviewing officers.
Application Correction: If any inconsistencies are found in the classification application, the review officer might ask the applicant to rectify the provided information. The applicant will have access to modify only the relevant section requiring updates, while other sections will be deemed final and subsequently locked for further changes.
Sample Request: MoHAP officers may seek further clarification or request the submission of product samples to conduct a more thorough evaluation of the product under consideration. The applicant is responsible for shipping the samples to MoHAP and providing the sample shipment details via the portal application. These details must include the name of the courier company, tracking number, and date of shipment.
Appointment Request: The officer may seek additional discussions or consultations regarding the application and propose an appointment with a suggested schedule. This process fosters direct communication between applicants and MoHAP officers, improving clarity and addressing any inquiries or concerns. The applicant has the option to either accept the proposed schedule or propose an alternative date and time.
Analysis Request: On occasion, MoHAP officers may instigate an examination of the medical product. This entails evaluating factors such as the product's composition, effectiveness, and safety measures. Applicants must remit fees for both analysis and certification. Following the assessment, applicants receive the analysis results, affording them the option to either accept the analysis or request re-evaluation if necessary. Additional fees are applicable for reanalysis. It is imperative that applicants respond within 60 working days, as failure to do so will lead to automatic acceptance of the analysis. Upon acceptance of the analysis results, applicants can download the analysis certificate
Once an application has been thoroughly reviewed and approved by a MoHAP officer, the applicant is issued a Product Classification Certificate. The Product Classification Letter issued by MoHAP includes the following particulars:
Application Number
Date of Issue
Expiry Date
Name of Applicant, along with City and Country
Committee M. No., along with the Date
Name and Form of the Product
Manufacturer's Name and Country
Classification Assigned
Timelines, Fees, and Validity
MoHAP strives to ensure efficiency in its processes, aiming for a turnaround time of 10 working days for product classification requests. The associated fee for product classification is AED 500, and the classification letter is valid for three years from the date of issue.
Navigating the regulatory landscape of the UAE's healthcare sector can be complex, but MoHAP's Product Classification process offers clarity and guidance for product owners. By understanding the nuances of classification, adhering to documentation requirements, and following the prescribed submission and review process, manufacturers and distributors can ensure compliance with UAE regulations and facilitate market access for their products.
Embark on your regulatory journey with confidence, leveraging MoHAP's Product Classification process as your roadmap to success in the UAE healthcare market.
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